Evidence map›Paper›PMID 22795453›Full record

Trial reportBiological psychiatry2012

Extended-release mixed amphetamine salts and topiramate for cocaine dependence: a randomized controlled trial.

John J Mariani, Martina Pavlicova, Adam Bisaga, Edward V Nunes, Daniel J Brooks, Frances R Levin

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Biological psychiatry, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 5 pooled it
4.2field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 5 syntheses or guidelines pooled it, 82 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Anticonvulsants for cocaine dependence.The Cochrane database of systematic reviews · 2015
    Pooled it
  5. Guideline
  6. Trial
  7. Open-label pilot study of lisdexamfetamine for cocaine use disorder.The American journal of drug and alcohol abuse · 2021
    Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Review
  15. Review
  16. Article
  17. Article
  18. Understanding Stimulant Use and Use Disorders in a New Era.The Medical clinics of North America · 2022
    Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

John J MarianiDivision of Substance Abuse, New York State Psychiatric Institute, New York 10032, USA.
Martina Pavlicova
Adam Bisaga
Edward V Nunes
Daniel J Brooks
Frances R Levin
Columbia University · USNew York State Psychiatric InstituteNew York State Office of Alcoholism and Substance Abuse Services · US

Funding

Substance Abuse Treatment Development and Clinical Research MentoringK24DA029647 · NIDA · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI LEVIN, FRANCES RUDNICK · 2010 to 2019
$1.8M
Drug Abuse Treatment Development and Research MentoringK24DA022412 · NIDA · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI NUNES, EDWARD V. · 2007 to 2016
$1.7M
Combined Pharmacotherapies for Cocaine DependenceR01DA022217 · NIDA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI LEVIN, FRANCES RUDNICK · 2006 to 2008
$1.0M
Anticonvulsant Pharmacotherapy for Sedative-Hypnotic Use DisordersK23DA021209 · NIDA · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI MARIANI, JOHN J · 2006 to 2010
$884k
Medical Research Council MC_U120036861NIDA NIH HHS K23 DA021209NIDA NIH HHS K24 DA022412NIDA NIH HHS K24 DA029647NIDA NIH HHS R01 DA022217PHS HHS K24 029647
6 · The paper itself

Abstract

backgroundCocaine dependence is a substantial public health problem, yet there are no clearly effective medication treatments. Amphetamine and topiramate have both shown promise for the treatment of cocaine dependence in preclinical and early-stage clinical studies.

methodsEighty-one cocaine-dependent adults were randomized to receive a combination of extended-release mixed amphetamine salts (MAS-ER) and topiramate or placebo for 12 weeks under double-blind conditions. MAS-ER doses were titrated over 2 weeks to a maximum dose of 60 mg daily, and topiramate doses were titrated over 6 weeks to a maximum dose of 150 mg twice daily. All participants received a supportive behavioral intervention. The primary outcome was the proportion of individuals who achieved 3 consecutive weeks of abstinence as measured by urine toxicology confirmed self-report.

resultsThe overall proportion of participants who achieved 3 consecutive weeks of abstinence was larger in the extended-release mixed amphetamine salts and topiramate group (33.3%) than in placebo group (16.7%). There was a significant moderating effect of baseline total number of cocaine use days (Wald χ(2) = 3.75, df = 1, p = .05) on outcome, suggesting that the combination treatment was most effective for participants with a high baseline frequency of cocaine use.

conclusionsThe results of this study supported our hypothesis that the combination of MAS-ER and topiramate would be superior to placebo in achieving 3 weeks of consecutive abstinence. These findings provide evidence that the combination of MAS-ER and topiramate is efficacious in promoting abstinence in cocaine-dependent individuals.

Indexed as

AdolescentAdultAmphetamineCocaine-Related DisordersDelayed-Action PreparationsDouble-Blind MethodDrug CombinationsFemaleFructoseHumansMaleMiddle AgedSelf ReportTopiramateTreatment OutcomeAmphetamineDelayed-Action PreparationsDrug CombinationsFructoseTopiramate

Identifiers

PMID22795453
PMCPMC3648884
OpenAlexW2056120061

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.